Method of preparing a double sterile package

Abstract

A method of preparing a sterile double package by inserting a sterile article into an inner package which has been sealed on three sides, inserting the inner package into an outer package which has three sides sealed, sealing the remaining side of the outer package to form a double package, sterilizing the contents of the outer package, and sealing the fourth side of the inner package through the outer package.

I claim: 
     
       1. A method of preparing a sterile double package including (1) a generally rectangular sealed inner package containing a sterile surgical article and comprising two opposed sealable layers of material sealed adjacent their peripheries and (2) a generally rectangular sealed outer package totally surrounding said inner package and comprising two opposed sealable layers of material sealed adjacent their peripheries with at least one of said opposed layers being vapor permeable, said inner package not being constrained from movement within said outer package, comprising the steps of (a) inserting a surgical article into said inner package, said inner package being sealed on three sides and open on the fourth side;   (b) inserting said inner package between said opposed layers of said outer package, with no more than three sides of said layers of the outer package being sealed, and then sealing the remaining sides of the outer package to totally enclose the inner package to form a double package;   (c) sterilizing the contents of the outer package by perfusion of a sterilizing gas through said vapor permeable layer thereof;   (d) removing gas vapors through vacuum, and,   (e) sealing the fourth side of the inner package adjacent the periphery thereof through the outer package,   with the conditions of the sealing operation of said step (e) and the materials of said opposed layers of said inner and outer packages being such that neither layer of said outer package is sealed to the adjacent layer of said inner package and said opposed layers of said outer package are not further sealed together during the sealing operation of said step (e).   
     
     
       2. The method of claim 1 wherein the material of inner package is foil laminate. 
     
     
       3. The method of claim 1 wherein the material of the outer package is comprised of one layer of high grade surgical paper and one layer of polypropylene laminated film. 
     
     
       4. A method of preparing a sterile double package including (1) a generally rectangular sealed inner package containing a sterile surgical article and comprising two opposed sealable layers of material sealed adjacent their peripheries and (2) a generally rectangular sealed outer package totally surrounding said inner package and comprising two opposed sealable layers of material sealed adjacent their peripheries with at least one of said opposed layers being vapor permeable, said inner package not being constrained from movement within said outer package, comprising the steps of: (a) inserting a suture into an inner package, said inner package comprised of foil laminate said inner package being sealed on three sides and open on the fourth side;   (b) inserting said inner package into an outer package, said outer package comprised of one layer of high grade surgical paper and one layer of polypropylene laminated film, said outer package being sealed on no more than three sides;   (c) sealing the remaining sides of said outer package at a temperature of from about 275° C. to 325° C. enclosing the inner package to form a double package;   (d) sterilizing the contents of the outer package by a perfusion of ethylene oxide gas through the high grade surgical paper layer thereof,   (e) removing gas vapors by placing the double package under vacuum; and,   (f) sealing the fourth side of the inner package adjacent the periphery thereof through the outer package, said sealing temperature of from about 200° C. to 250° C.